Strategic Regulatory Affairs Biosimilars - LATAM

Exeltis; Madrid; Presencial; EUR 80.000 - 110.000; Jornada completa

Descripción de la vacante

Exeltis is seeking a Regulatory Affairs Biosimilar Specialist to lead regulatory strategies for biosimilars across international markets, based in Madrid. The role requires a strategic mindset, strong influencing skills and extensive experience in regulatory submissions.

You will collaborate with R&D, BD and Commercial teams, manage submissions (IBs/INDs/CTAs/MAAs), guide Health Authority interactions and drive risk mitigation and digitalization within the function.

Formación

• Degree in Health Sciences, preferably Pharmacy.
• More than 5 years of experience in Regulatory Affairs within innovative biopharmaceuticals and/or biosimilars.
• Fluent English and Spanish.
• Knowledge of biosimilar registrations with ANVISA (Brazil).

Responsabilidades

• Define regulatory strategy for each product with Regulatory Affairs Director and cross-functional teams.
• Monitor regulatory landscape changes and identify impact on the company.
• Prepare and manage regulatory submissions (IBs, INDs, CTAs, MAAs).
• Lead Health Authority interactions during Scientific Advice procedures.
• Support Business Development and Commercial Operations with regulatory input on licenses and agreements.
• Drive risk mitigation and digitalization within the Regulatory function.

Conocimientos

Regulatory strategy

Cross-functional collaboration

Regulatory leadership

Influencing skills

Regulatory intelligence

Educación

Degree in Health Sciences/Pharmacy

Chemistry/Biology related degree

Herramientas

Word

Excel

PowerPoint

MS Project

Descripción del empleo

Exeltis is seeking a Regulatory Affairs Biosimilar Specialist to lead regulatory strategies for biosimilars across international markets, based in Madrid. The role requires a strategic mindset, strong influencing skills and extensive experience in regulatory submissions.

You will collaborate with R&D, BD and Commercial teams, manage submissions (IBs/INDs/CTAs/MAAs), guide Health Authority interactions and drive risk mitigation and digitalization within the function.